LOGO: GMP Manual (Based on cGMP requirements according to AO 153) Our Company Street Address City, State Country Postal Code Page 1 of 18 List other references used in the development of your manual Terms and definitions List terms that you use that should be defined. The headers are in the following Microsoft Word Styles associated with this DOCument: Section Heading (followed by the tab to bring line to the page edge) Heading 2 Body Text Heading 3 Body Text Page 2 of 18 . product categories. processes and production sites that are included in your system. Replace the words “The Company” and “The Company’s” with your company name. Include the products. Maybe Codex Alimentarius on Good Hygiene Practices! Instructions for this Manual: Use the AO 153 as a reference as you modify this manual to apply to your System.Scope Write a paragraph here to clearly identify the scope of your system. Any red text is instructional and should be deleted from the manual. Normative References Administrative Order 153 issued by FDA. Page 3 of 18 . 2. Training All our staff undergoes continuous training. Page 4 of 18 . and Responsibilities The company’s Quality System has been designed to ensure the provision of safe. The training and awareness process is documented in our Training and Awareness Procedure (SOP – A – 201 Training and Awareness).A GMP Organization 1 Organization. in GMP and Food Safety and is qualified for their job duties. Qualification. The company has established different departments to ensure the strict implementation of these GMP guidelines as indicated in the organizational chart (see SOP – A – 101 Organizational Chart). updated and validated. quality products to our customers. The System has been built and implemented based upon the principles and requirements of the current Good Manufacturing Practices (GMP) issued by the Philippine FDA in the AO 153. The responsibilities of the different managerial and supervisory staff are clearly defined (see SOP– A-102 Job Descriptions). which is regularly instituted. Plant Construction and Design Plant. - Process flow. The Company´s Master Plan Diagram (see SOP – B – 201 Master plan ) provides an overview of relevant Food Safety issues: - Building outline with production areas. waste water drain off - Definition of areas – in terms of hygiene zones and functions - Drinking water supply List other relevant details! Minimum design and constructions requirements of plant facilities are fulfilled and our Company has used materials which are suitable for food processing Page 5 of 18 . raw material flow. It is constructed and maintained to protect it from contaminants.B Premises 1. - Waste collection area.1 in AO 153 for General Maintenance) List other measure you are taking to keep good your premises well maintained! 2. Grounds Our company is located in an area away from major pollutants. building and structures are designed in a way to comply with the requirement of the cGMP and to minimize the risk of cross contamination that will affect the safety of the product. This is the same procedure as for preventive maintenance! (see 5. service areas and surroundings. Good housekeeping is applied according to our Maintenance of Premises Procedure (SOP – B – 101 General Maintenance of Plant and Premises). worker’s flow. Page 6 of 18 .(see SOP – B – 202 Explanatory leaflet of materials used and techniques of constructions employed). Cleaning and Sanitation Program (SOP – D – 501 Maintenance. this can also be called “List of equipment” It is the company’s policy to minimize all glass parts at equipment. Page 7 of 18 . If equipment contains glass part it is indicated in the Glass Register (SOP – C – 102). Cleaning and Sanitation Program). All equipment is installed with adequate space from each other in order to minimize cross-contamination as indicated in the company´s Master Plan Diagram (see SOP – B – 201 Master plan ) All equipment will be cleaned and maintained according to the company’s Maintenance. Equipment All equipment used for food production is designed and constructed in a way as to minimize cross-contamination during production and to facilitate easy cleaning. Details about the equipment used for production can be seen in the company’s Explanatory leaflet of the equipment and machines (SOP – C – 101). Possibly.C. All material used for the construction of equipment is resistant to corrosion and non-toxic. D. Sanitation and Hygiene 1. or any other possible source of microbial contamination is excluded until the condition is corrected. an illness. sores. 1. All employees must adhere to the company’s policy in regard to hygienic practices. records.1. open lesion. Personnel 1. Training is a good a way to show to the inspector that employee have been made aware of Disease Control and Personal Hygiene. Define where you will keep these kinds of records. (SOP – D – 121). including boils. Prior to work every newly hired employee will undergo a medical check-up to examine his/her health condition. Please define what kind of procedures. or infected wounds. Adequate protective clothing will be provided by the company. or appears to have.2 Hygienic Practices It is the company’s policy that all personnel who handle food or are involved in the food processing are obliged to act according to hygienic practices while on duty to the extent necessary to protect against contamination of food. Regular check-ups will be held according to our Disease Control Procedures (SOP – D – 111) Health certificates of each employee are required by the Management. etc you want to have to show to the inspector that you comply with this clause: Page 8 of 18 . Comment: This can be stated in the SOP. Disease Control It is one of the company’s policies that any personnel who is shown to have. The responsibilities of the different managerial and supervisory staff are clearly defined (see SOP– A-102 Job Descriptions). Sanitary Facilities The company provides all necessary sanitary facilities as follows: List up what sanitary facilities you provide.: Water supply – you might use potable water for production and nonpotable water for other purposes. in GMP and Food Safety and is qualified for their job duties. etc…. Describe how you would supervise that everybody follows the policy. Describe handwashing procedures. Education and Training All our staff undergoes continuous training. Supervision Authority and responsibilities are clearly assigned according to the company’s organizational chart to ensure compliance (see DOC – A – 101 Organizational Chart). The training and awareness process is documented in our Training and Awareness Procedure (SOP – A – 201 Training and Awareness). updated and validated. 3. Describe it here! Effluent and Waste diposal Changing facilities Toilets Page 9 of 18 . 4. Describe training.Pointers: SOP – D – 121 Hygienic Practices Policy: (Describe what protective clothing you want your employees to wear.) 2. which is regularly instituted. e.g. Cleaning and Sanitation Program The establishments and equipment of the company are regularly maintained. wire mesh screens or electrocution traps taken by the company in order to control pest and vermin within the premises. Employees responsible for maintenance. Maintenance and Sanitation 5. Cleaning and Sanitation Program (SOP – D – 511 Maintenance. Measures such as e. 5. Page 10 of 18 . cleaning and sanitation are appropriately trained on relevant fields regarding food safety according to the company’s Training and Awareness Procedure (SOP – A – 201 Training and Awareness). Cleaning and Sanitation Program).Handwashing Facilities Disinfection facilities (only if you consider them necessary) Facilities for storage of waste and inedible material Eating facilities Others All these sanitary facilities are indicated in the company’s Master Plan Diagram (see SOP – B – 201 Master plan). For the company good maintenance is a must/a prerequisite to ensure and facilitate proper sanitation procedures and to prevent possible contamination from metal shards. debris and chemicals. flaking plasters.1 General Maintenance.2 Pest Control All kind of animals are strictly excluded and prevented from all food processing activities according to company’s policies. 5.g. cleaned and sanitized according to the company’s Maintenance. Additionally. the company contracts an external pest control company to operate an effective pest control program in all relevant areas of the company. Page 11 of 18 . (SOP – D – 521 Pest Control Program). Production and Process Controls 1. The accuracy of the diagrams is verified through on-site checking by qualified personnel. A flow diagram is prepared and used as a basis for evaluating food safety hazards.g. Suppliers are requested to submit a certificate of analysis for their product.1 Raw Materials and other Ingredients Raw materials and other ingredients are inspected and controlled at the receiving and must apply to the company’s specifications (SOP – E – 1.1 Raw Material Specification List). The flow diagram identifies the existing control measures. (You might also request the supplier for a letter of guarantee or certificate of analysis – this is an important Document! Consider this and specify!: e. Production Processes and Controls The process flow is designed in a way that all operations are conducted in accordance to sanitation principles and guarantee Food safety of the products.1. Page 12 of 18 .2 List of COAs) They are properly stored to protect against contamination and to minimize deterioration (see SOP – E – 101 Flow Diagram and Process Description). (maybe also by the Food Safety Team if already founded – better!). process parameters or procedures that influence food safety as well as relevant external requirements (SOP – E – 101 Flow Diagram and Process Description). (Consider: You might need more than one flow diagram to describe your processes!) 1. see DOC 1.1.E. 1. quality and safety of the product are monitored (see SOP – E – 101 Flow Diagram and Process Description). Browse through clause 1. they are registered in the company’s Glass register (SOP – C – 102 Glass register). Physical factors important for the consistency. maybe in the process flow diagram! Indicate relevant Documents! Page 13 of 18 . Where glassware or glass parts are used. Glass within the production is generally avoided. Cleaning and Sanitation Program (SOP – D – 511 Maintenance.2 Manufacturing Operations All manufacturing operations necessary for the sanitary handling and maintenance of equipment and utensils are established. utensils and finished food containers are maintained in a sanitary condition according to the company’s Maintenance. Equipment.2 Manufacturing operations and decide which clauses are relevant for your company and describe how you would deal with them. Cleaning and Sanitation Program). Any returned products that do not comply with the original specification will be rejected and disposed as described in the Deviations Procedure (SOP – F – 201 Deviations Procedure).F. bulk and finished product. the company will decide what actions will be taken to guarantee Food Safety of the product (SOP – F – 201 Deviations Procedure). Page 14 of 18 . Consider quality as well as food safety issues! Consider: Review of batch Documentation Sample retention program Stability studies (if necessary) Product complaints Product recalls Specifications of materials and products 2. Testing of Reprocessed Products and Testing of Returned Goods If deviations at critical control points or control point occur. Additional testing of finished product will be performed if considered necessary. Check with the BFAD requirements (List of laboratory analysis for food microbiology and food chemistry). Decide what kind of testing you want to establish in your company. Quality Control 1. Quality Management The company’s quality control system is established. in process. intermediate. Returned goods are stored separately and tested if necessary. In case of reprocessing the finished product will be tested again. inspecting of starting materials. It involves sampling. Page 15 of 18 . quality and consistency and approved before implementation. review. availability of current Documents at point of use. update and re-approval of Documents. legibility and identification of Documents. Work Instructions and Records. Documentation The company’s GMP-system is Documented in this GMP Manual. retention time. Page 16 of 18 . identification of changes and current revision. protection. The procedure defines identification.G. The company’s Document control process ensures that all GMP Documents are controlled. The procedure defines Document control including Document approval. storage. retrieval. The company controls records according to our Quality Records Procedure. This process is Documented in our Document Control Procedure (SOP – G – 101 Control of Documents). and disposition methods. All proposed changes are reviewed for their effect on food safety. Procedures. (SOP – G – 102 Control of Records) This process addresses the steps required to establish and maintain our records to demonstrate the company’s conformance to GMP requirements as well as regulatory requirements. control of Documents of external origin and prevention of unintended use of obsolete Documents. whether received orally of in writing. chemical and microbial contamination as well as against deterioration of the food and the container. scope. market returns or complaint goods - Security and tidiness of storage facilities J. defective stock. Audits determine whether the system conforms to the requirements An Internal Audit procedure describes the audit process. frequency and methods used for the audit process. Product Recall All quality or safety-related complaints. FEFO) - Separate storage of goods from chemicals. The company’s Warehousing and Distributions Procedure describes the sanitary handling of the product considering (SOP – I – 101 Warehousing and Distribution Procedure): - Stock rotation (FIFO.H. I. Warehousing and Distribution The company has established procedures for sanitary handling of food on storage and distribution in order to protect the product against physical. Quality Audits Internal audits are conducted to verify the effectiveness of the GMP system. A report will be made at the completion of each quality audit. Page 17 of 18 . responsibilities and authorities (SOP – H – 101 Internal Audit Procedure) The procedure defines the criteria. potentially contaminated incoming materials. are recorded and investigated by the company. agreed and controlled. All lots of product that may have been affected by non-conformity are held under control until they have been evaluated. Retention of Samples Retention Samples are withdrawn from the production as described in SOP – E – 101 Flow Diagram and Process Description L. Page 18 of 18 . Pointer: This clause might be not relevant for your company but maybe you have a contracted pest control company. If any product has left control of The Company a recall is initiated according to Product Recall Procedure (SOP – J – 102 Product Recall Procedure). Actions are taken to prevent any nonconforming product from entering the food chain unless it has been determined that the food safety hazard has been reduced to stated acceptable levels or will be before entering the food chain or that the product meets acceptable levels despite of the nonconformity. Relevant Documents are kept. K.After evaluation corrective actions are taken according to the company’s Customer Complaints Handling Procedure (SOP – J – 101 Customer Complaints Handling Procedure). Sub-Contracting of Manufacture The conditions of contract manufacturing (if any) will be defined.